临床试验/NCT06263998

NCT06263998招募中1 期

A Randomized, Double-blind, Parallel, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Clinical Study to Assess the Safety, and Local Tolerance, Pharmacokinetics After Application of NCP112 Eye Drop in Healthy Subjects

Huons Co., Ltd.1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2024年7月11日最近更新: 2024年10月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Huons Co., Ltd.
入组人数: 60
试验地点: 1
主要终点: Eye irritation(Likert scale)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective is to evaluate the safety, local tolerability, and pharmacokinetics of NCP112 eye drops through single and multiple dose-escalation ocular administrations in healthy adults.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 19 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy adult subjects aged 19 to 50 years at the time of screening (Visit 1).
•Subjects with a body weight of 50.0 kg or more, and a body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of screening (Visit 1).
•※ Body Mass Index (BMI, kg/m²) = Weight (kg) / [Height (m)]²
•Subjects who have received sufficient explanation about the clinical trial, fully understand it, and have voluntarily decided to participate and signed the written informed consent.
•Subjects deemed suitable as participants for this clinical trial based on the investigators judgment after physical examination, clinical laboratory tests, and medical history obtained during screening (Visit 1).

排除标准

•Subjects with clinically significant diseases or history of diseases related to the liver, kidneys, cardiovascular system, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system (such as epilepsy, mood disorders, obsessive-compulsive disorder), hematologic/oncologic system, or urinary system (chronic or recurrent urinary tract infections).
•Subjects with hepatitis B or C.
•Subjects meeting any of the following criteria based on ophthalmologic history or examination during screening (Visit 1):
•Corrected visual acuity of 20/40 or less.
•Intraocular pressure exceeding 21 mmHg in either eye.
•History of lacrimal drainage system disease or abnormal tear drainage.
•History or suspicion of conditions affecting visual organs such as keratitis, iritis, uveitis, retinitis, dry eye syndrome, strabismus, glaucoma, etc.
•Experience of adverse effects from contact lens use, or contact lens use within one month prior to the anticipated first dose, or inability to abstain from contact lens use during the clinical trial.
•Ophthalmologic surgery (intraocular surgery) or laser vision correction surgery (such as LASIK) within 12 months prior to the anticipated first dose.
•Silicone punctal occlusion or punctal cauterization within 3 months prior to the anticipated first dose (collagen punctal occlusion within 1 month).
•Any other abnormal findings from ophthalmologic examination.
•Subjects with a history of hypersensitivity to the active ingredients or excipients of the investigational drug, or to drugs in the same class as the active ingredients.
•Subjects who have taken any medications related to dry eye syndrome (e.g., artificial tears, anti-inflammatory agents like cyclosporine, hyaluronic acid preparations, tetracycline preparations) or drugs that could induce dry eye syndrome or affect the outcome of this clinical trial (e.g., oral contraceptives, antihistamines, sedatives, oral aspirin, corticosteroids) within one month prior to the anticipated first dose.
•Subjects who have taken any prescription drugs, eye drops other than those for dry eye, oriental medicine, or any other health supplements, including liver function supplements or vitamins within 2 weeks of the expected first dosing date, or any over-the-counter drugs within 1 week (unless other conditions are deemed appropriate by the investigator).
•Subjects who have taken drug metabolism inducers or inhibitors, such as barbiturates, within one month prior to the expected first dosing date
•Subjects with a history of drug abuse or a positive result on a urine drug test at screening (Visit 1).
•Subjects unable to restrict grapefruit or grapefruit-containing food consumption from 7 days prior to the anticipated first dose through the duration of the clinical trial.
•Subjects with systolic blood pressure of 90 mmHg or less, or 140 mmHg or more, or diastolic blood pressure of 50 mmHg or less, or 90 mmHg or more after sitting for at least 3 minutes without sudden postural changes during screening (Visit 1).
•Subjects with a history of alcohol abuse, or who have consumed alcohol regularly (more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) within one month prior to the anticipated first dose, or are unable to abstain from alcohol during the clinical trial.
•Subjects who regularly consume caffeine (e.g., coffee or green tea more than 5 units/day) or are unable to abstain from caffeine-containing foods from 24 hours prior to hospitalization through the duration of the clinical trial.
•Subjects who have regularly smoked (including e-cigarettes, more than 10 cigarettes/day) within one month prior to the anticipated first dose, or are unable to abstain from smoking during the clinical trial.
•Subjects who test positive on a breath alcohol test at screening (Visit 1).
•Subjects who have participated in another clinical trial and received an investigational drug within 6 months prior to the anticipated first dose.
•Subjects who have donated whole blood within 2 months, or component blood within 1 month, or received a blood transfusion within 1 month prior to the anticipated first dose, or who plan to donate or receive blood during the clinical trial.
•Subjects who have received a vaccine within 14 days prior to the anticipated first dose or are expected to receive a vaccine during the trial period.
•Female participants who test positive on a pregnancy test (urine hCG) conducted before the start of investigational drug administration, are pregnant, or are breastfeeding, except for those who have undergone surgical sterilization (Bilateral tubal ligation, Bilateral oophorectomy, or Hysterectomy).
•Subjects who, during the entire clinical trial period and for at least 90 days after the last dose of the investigational drug, cannot or do not agree to use medically acceptable double contraception methods, or whose partner cannot or does not agree to use medically acceptable contraception, or who do not agree to refrain from donating sperm during this period.
•※ Medically acceptable contraception methods include:
•Use of an intrauterine device (IUD) with a documented failure rate by the partner.
•Double contraception (use of barrier methods by both male and female partners).
•Surgical sterilization of the subject or partner (vasectomy, tubal ligation, hysterectomy).
•Subjects deemed unsuitable for participation by the investigator for other reasons (e.g., non-compliance with instructions).

研究组 & 干预措施

Single Ascending dose NCP112 Dose A

Experimental

NCP112 is administered once at a specified time in Day 1

干预措施: NCP112 (Drug)

Single Ascending dose NCP112 Dose A, Placebo

Placebo Comparator

NCP112 Placebo is administered once at a specified time in Day 1

干预措施: NCP112 Placebo (Drug)

Single Ascending dose NCP112 Dose B

Experimental

NCP112 is administered once at a specified time in Day 1

干预措施: NCP112 (Drug)

Single Ascending dose NCP112 Dose B, Placebo

Placebo Comparator

NCP112 Placebo is administered once at a specified time in Day 1

干预措施: NCP112 Placebo (Drug)

Single Ascending dose NCP112 Dose C

Experimental

NCP112 is administered once at a specified time in Day 1

干预措施: NCP112 (Drug)

Single Ascending dose NCP112 Dose C, Placebo

Placebo Comparator

NCP112 Placebo is administered once at a specified time in Day 1

干预措施: NCP112 Placebo (Drug)

Multiple Ascending dose NCP112 Dose A

Experimental

NCP112 is administered twice daily. [time frame: Day 1- Day 14]

干预措施: NCP112 (Drug)

Multiple Ascending dose NCP112 Dose A, Placebo

Placebo Comparator

NCP112 Placebo is administered twice daily. [time frame: Day 1- Day 14]

干预措施: NCP112 Placebo (Drug)

Multiple Ascending dose NCP112 Dose B

Experimental

NCP112 is administered twice daily.[time frame: Day 1- Day 14]

干预措施: NCP112 (Drug)

Multiple Ascending dose NCP112 Dose B, Placebo

Placebo Comparator

NCP112 Placebo is administered twice daily. [time frame: Day 1- Day 14]

干预措施: NCP112 Placebo (Drug)

Multiple Ascending dose NCP112 Dose C

Experimental

NCP112 is administered twice daily.[time frame: Day 1- Day 14]

干预措施: NCP112 (Drug)

Multiple Ascending dose NCP112 Dose C, Placebo

Placebo Comparator

NCP112 Placebo is administered twice daily. [time frame: Day 1- Day 14]

干预措施: NCP112 Placebo (Drug)